CClinicalTrials.gg
CompletedNCT04292366Updated Sep 29, 2021

Optimising Colorectal Cancer Screening Participation

An interventional study of Invitation procedure in Colorectal Neoplasms, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-09-29.

Sponsored by University of Aarhus · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
60,000
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study summary

The aim of this study is to demonstrate the effectiveness of three and four-staged invitation procedures compared to two-staged procedures by combining pre-notifications and reminders. The RCT will be nested into the Danish colorectal cancer screening programme in the Central Denmark Region including men and women aged 50-74 years. Participants will consecutively be randomized into four arms in a 1:1 ratio. Intervention arm 1 will receive a pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention), Intervention arm 2 will receive invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure), Intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure). Finally, the forth arm will be a control group receiving usual care which invitation and one reminder 45 days after invitation (two-staged invitation procedure). Both pre-notifications and reminders are sent using digital mail.

The main out-come will be participation within 6 months after invitation.

02

Conditions studied

  • Colorectal Neoplasms

Keywords

  • mass screening
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 60,000 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Invited for colorectal cancer screening

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60,000 participants (actual)

Study arms

  • Experimental
    Intervention arm I

    pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)

    Procedure: Invitation procedure

  • Experimental
    Intervention arm II

    invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure)

    Procedure: Invitation procedure

  • Experimental
    Intervention arm III

    pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure)

    Procedure: Invitation procedure

  • Active comparator
    Control group

    invitation and one reminder after 45 days (usual care)

    Procedure: Invitation procedure

Interventions

  • ProcedureInvitation procedure

    Optimised invitation procedures in an organised colorectal cancer screening programme

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What researchers measure

Primary outcomes

  1. Number of residents participating in colorectal cancer screening

    Number of residents participating in colorectal cancer screening in each of the four arms

    Time frame: Within six months after invitaiton

07

Study locations

1 site
  • Randers Regional Hospital
    Randers, 8930, Denmark
08

References and documents

Publications

  • Larsen MB, Hedelund M, Flander L, Andersen B. The impact of pre-notifications and reminders on participation in colorectal cancer screening - A randomised controlled trial. Prev Med. 2022 Nov;164:107229. doi: 10.1016/j.ypmed.2022.107229. Epub 2022 Aug 31. PubMed 36057390 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04292366
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Mar 3, 2020
Start date
Oct 2, 2020
Primary completion
May 10, 2021
Completion
May 10, 2021
Last update
Sep 29, 2021

Study contacts

Berit Andersen, Professor
study director · Randers Regional Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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